Chronic Disease Research Institute, School of Public Health, and Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Department of Nutrition and Food Hygiene, School of Public Health, Zhejiang University, Hangzhou, Zhejiang, China.
PLoS Med. 2020 Feb 24;17(2):e1003047. doi: 10.1371/journal.pmed.1003047. eCollection 2020 Feb.
China implemented a partial two-child policy (2013) followed by a universal two-child policy (2015), replacing the former one-child policy mandated by the government. The changes affect many aspects of China's population as well as maternal and infant health, but their potential impact on birth defects (BDs) remains unknown. In this study, we investigated the associations of these policy changes with BDs in Zhejiang Province, China.
We used data from the BD surveillance system in Zhejiang Province, China, which covers 90 hospitals in 30 urban districts and rural counties, capturing one-third of the total births in this province. To fully consider the time interval between conception and delivery, we defined the one-child policy period as data from 2013 (births from October 2012 to September 2013), the partial two-child policy period as data from 2015 (births from October 2014 to September 2015), and the universal two-child policy period as data from 2017 (births from October 2016 to September 2017). Data from 2009 and 2011 were also used to show the changes in the proportion of births to women with advanced maternal age (35 years and older) prior to the policy changes. Main outcome measures were changes in the proportion of mothers with advanced maternal age, prevalence of BDs, rankings of BD subtypes by prevalence, prenatal diagnosis rate, and live birth rate of BDs over time. A total of 1,260,684 births (including live births, early fetal losses, stillbirths, and early neonatal deaths) were included in the analyses. Of these, 644,973 (51.16%) births were to women from urban areas, and 615,711 (48.84%) births were to women from rural areas. In total, 135,543 (10.75%) births were to women with advanced maternal age. The proportion increased by 85.68%, from 8.52% in 2013 to 15.82% in 2017. However, it had remained stable prior to policy changes. Overall, 23,095 BDs were identified over the policy changes (2013-2017). The prevalence of BDs during 2013, 2015, and 2017 was 245.95, 264.86, and 304.36 per 10,000 births, respectively. Trisomy 21 and other chromosomal defects increased in both risk and ranking from 2013 to 2017 (crude odds ratio [95% confidence interval] 2.13 [1.75-2.60], from ranking 10th to 5th, and 3.63 [2.84-4.69], from ranking 16th to 6th, respectively). The prenatal diagnosis rate increased by 3.63 (2.2-5.1) percentage points (P < 0.001), from 31.10% to 34.72%, and identification of BDs occurred 1.88 (1.81-1.95) weeks earlier (P < 0.001). The live birth rate for infants with BDs born before 28 gestational weeks increased from 1.29% to 11.45%. The major limitations of this observational study include an inability to establish causality and the possible existence of unknown confounding factors, some of which could contribute to BDs.
In this study, we observed significant increases in maternal age and the prevalence of total and age-related anomalies following China's new two-child policy. Increases in live birth rate for infants with BDs born before 28 gestational weeks suggest that healthcare for very preterm births with BDs may be warranted in the future, as well as updating the definition of perinatal period.
中国于 2013 年实施了部分二孩政策,随后于 2015 年全面实施二孩政策,取代了原有的政府规定的一孩政策。这些变化影响了中国人口的许多方面以及母婴健康,但它们对出生缺陷(BDs)的潜在影响仍不清楚。在这项研究中,我们调查了这些政策变化与中国浙江省 BDs 之间的关联。
我们使用了中国浙江省 BDs 监测系统的数据,该系统涵盖了 30 个市区和农村县的 90 家医院,占该省总出生人数的三分之一。为了充分考虑受孕和分娩之间的时间间隔,我们将一孩政策时期定义为 2013 年的数据(2012 年 10 月至 2013 年 9 月的出生人数),部分二孩政策时期定义为 2015 年的数据(2014 年 10 月至 2015 年 9 月的出生人数),全面二孩政策时期定义为 2017 年的数据(2016 年 10 月至 2017 年 9 月的出生人数)。还使用了 2009 年和 2011 年的数据来显示政策变化前母亲年龄(35 岁及以上)生育比例的变化。主要观察结果是母亲年龄、BDs 患病率、按患病率排名的 BD 亚型、产前诊断率和 BDs 的活产率随时间的变化。共有 1260684 例(包括活产、早期胎儿丢失、死产和早期新生儿死亡)出生纳入分析。其中,644973 例(51.16%)出生于城市地区的妇女,615711 例(48.84%)出生于农村地区的妇女。共有 135543 例(10.75%)出生于高龄产妇。这一比例增加了 85.68%,从 2013 年的 8.52%增加到 2017 年的 15.82%。然而,在政策变化之前,这一比例一直保持稳定。总体而言,在政策变化期间(2013-2017 年)共发现 23095 例 BDs。2013 年、2015 年和 2017 年 BDs 的患病率分别为 245.95、264.86 和 304.36/10000 人。2013 年至 2017 年,21 三体和其他染色体缺陷的风险和排名均有所上升(粗比值比[95%置信区间]2.13[1.75-2.60],从第 10 位上升到第 5 位,3.63[2.84-4.69],从第 16 位上升到第 6 位)。产前诊断率提高了 3.63(2.2-5.1)个百分点(P<0.001),从 31.10%上升到 34.72%,BDs 的检出时间提前了 1.88(1.81-1.95)周(P<0.001)。28 孕周前出生的 BDs 患儿的活产率从 1.29%上升到 11.45%。本观察性研究的主要局限性包括无法确定因果关系以及可能存在未知的混杂因素,其中一些因素可能导致 BDs。
在这项研究中,我们观察到中国新的二孩政策后,母亲年龄和总畸形及年龄相关畸形的患病率显著增加。28 孕周前出生的 BDs 患儿的活产率从 1.29%上升到 11.45%,这表明未来可能需要为非常早产儿的 BDs 提供医疗保健,并更新围产期的定义。